E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute phase Adenoviral-induced Epidemic Keratoconjunctivitis, EKC |
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E.1.1.1 | Medical condition in easily understood language |
EKC (epidemic keratoconjunctivitis) is a contagious viral eye infection. It is painful, reduces vision during the acute phase and may eventually lead to reduced vision that last for months or years. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014975 |
E.1.2 | Term | Epidemic keratoconjunctivitis |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the adenoviral load in epidemic keratokonjunctivitis (EKC) infected eyes following topical treatment with APD-209 Eye drops given 8 times daily for 14 days compared to placebo. |
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E.2.2 | Secondary objectives of the trial |
• Assess the time to viral eradication in EKC infected eyes following treatment with APD 209 Eye drops compared to placebo.
• Evaluate the effect of APD 209 Eye drops on clinical resolution of EKC, as measured by objective and subjective assessment of scaled clinical symptoms, compared to placebo.
• Evaluate the presence of opacities (quantitatively and qualitatively) following treatment with APD 209 Eye drops compared to placebo.
• Assess the visual acuity following treatment with APD 209 Eye drops compared to placebo.
• Assess the frequency of second eye infections.
• Assess the safety and tolerability of APD 209 Eye drops. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men or women aged 18 years or above with onset of adenoviral EKC symptoms in at least one eye, as diagnosed according to current clinical practice, and with symptoms appearing within less than 7 days at the time of giving informed consent will be included in the study. |
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E.4 | Principal exclusion criteria |
1) Known or suspected allergy to any ingredient of the IMP or placebo.
2) Symptoms correlating with EKC since more than 7 days.
3) Diagnosis of other significant disease(s) than EKC in the eye.
4) Diagnosis of bacterial or fungal ocular infections, as assessed by the Investigator.
5) Use of antibiotics or corticosteroids by any route (except intravitreal corticosteroids) within 14 days prior to inclusion. Ocular antibiotics may, however, be used until 2 hours prior to first dose of IMP, but are thereafter prohibited during the study.
6) Use of immunosuppressive medications (including intravitreal corticosteroids) within 6 months prior to inclusion.
7) Use of antiviral medications within 7 days prior to inclusion.
8) Usage of any medication or herbal medicinal product with documented adverse reactions affecting the eyes, assessed by the Investigator as being relevant for the study.
9) Usage of any medication or herbal medicinal product for ocular administration at inclusion.
10) Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study period.
11) Known or suspected drug abuse.
12) Usage of contact lenses during the study.
13) Participation in any other interventional clinical study within 30 days prior to inclusion.
14) Previous inclusion in this study.
15) Living together with a person who is already included in this study.
16) Any other reason that, in the opinion of the Investigator, makes the patient unsuitable for participation in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Virological success as measured by a reduction of viral load in tear liquid from EKC infected eyes, as measured by the area under the curve (AUC) at 3-14 days from start of treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Virological success as measured by a reduction of viral load in tear liquid from EKC infected eyes, as measured by the AUC at 0-14 days from start of treatment.
• To determine the time point of viral eradication in tear liquid from EKC infected eyes, defined as the time point when viral load=0 or below the lower limit of quantification (LLOQ).
• To assess resolution of acute ocular symptoms at each time of assessment, as measured by objective (Investigator-based) assessment of conjunctival discharge and redness.
• To assess resolution of ocular symptoms at each time of assessment, as measured by subjective (Patient Worksheet) assessment of irritation, foreign body sensation, tearing, pain and blurred vision.
• To assess presence and location of opacities at each time of assessment, as measured by slit lamp examination.
• To assess visual acuity at each time of assessment by use of the logarithm of the Minimum Angle of Resolution (LogMAR) chart.
• To assess occurrence of second eye infection.
Safety of APD-209 by recording of
• Adverse events (AEs) (nature and incidence)
• Physical examination
• Vital signs
• Laboratory safety assessments (haematology, clinical chemistry and urinalysis)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 2 |